Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

NCT06855758 | Recruiting

• 1 other identifier: 2025-P2-023-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure maintenance and the dosage of the vasoactive drug, postoperative graft function, delayed graft function, and other related complications between the two groups, in order to demonstrate whether the use of terlipressin for blood pressure regulation during kidney transplantation is superior to the existing treatments.

Conditions

Kidney Transplant; Delayed Graft Function; Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

• Delayed graft function

  need kidney replacement in the first 7 days after op

  within the first 7 days after op

Study Arms (2)

dopamine

NO INTERVENTION

Continuous using of dopamine as blood pressure regulation after anesthesia, with dosage adjusted according to intraoperative needs

terlipressin + dopamine

EXPERIMENTAL

Terlipressin was given before the graft circulation was established while continuous using of dopamine during the whole operation

Drug: terlipressin

Interventions

terlipressin DRUG

Terlipressin was given prior to the opening of the graft circulation (with the possibility of reperfusion hypotension) when the blood pressure is suboptimal and does not respond well to dobutamine or fluid volume resuscitation. 1 mg terlipressin + 100 ml of sodium chloride injections was given for intravenous infusion.

terlipressin + dopamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with end-stage renal disease aged 18 years or above

You may not qualify if:

• simultaneous multiple organ transplantation
• known allergy to study medication
• known pregnancy status
• cancellation of surgery due to grafts or personal reasons
• persistent severe preoperative hypertension that may not require intraoperative supportive therapy with vasoactive medications
• any other reason that the supervising physician or the anesthesiologist on duty think the patient is not suitable for the study

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Fushan Xue

  Department of Anesthesiology, Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhe Yang

CONTACT

86 13810673664; 13810673664@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 6, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after published
• Access Criteria: Investigators who submitting research proposals and signing agreements of data using with corresponding authors

Locations

CN (1)